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ISO 11930:2019 (E)
ISO - Cover page
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Preservation efficacy test
 5.1 General
 5.2 Materials, apparatus, reagents and culture media
  5.2.1 General
  5.2.2 Materials
  5.2.3 Diluents
  5.2.4 Neutralizer
  5.2.5 Culture media
 5.3 Microbial strains
 5.4 Preparation and enumeration of inocula
  5.4.1 General
  5.4.2 Preparation of bacterial and Candida albicans suspensions
  5.4.3 Preparation of Aspergillus brasiliensis spore suspension
 5.5 Demonstration of the neutralizer efficacy
  5.5.1 Principle
  5.5.2 Procedure
  5.5.3 Calculations
  5.5.4 Interpretation of results and conclusion on neutralizer efficacy
 5.6 Determination of the preservation efficacy of the formulation
  5.6.1 Procedure
  5.6.2 Counting of colonies
  5.6.3 Calculations
 5.7 Interpretation of test results and conclusions
  5.7.1 Criteria
  5.7.2 General case (efficacy of the neutralizer is demonstrated for all strains)
  5.7.3 Case of formulations for which the efficacy of the neutralizer is not demonstrated for some strains
 5.8 Test report
6 Overall evaluation of the antimicrobial protection of the cosmetic product
 6.1 General
 6.2 Case 1 — Preservation efficacy test has been performed on the formulation
 6.3 Case 2 — Preservation efficacy test has not been performed on the formulation
Annex A (normative) Decision diagram
Annex B (normative) Evaluation criteria for the preservation efficacy test
Annex C (informative) Examples of neutralizers for the antimicrobial activity of preservatives and washing liquids
Annex D (informative) Packaging characteristics
Bibliography

INTERNATIONAL

STANDARD

ISO
11930
Second edition
2019-01



Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
Cosmétiques — Microbiologie — Évaluation de la protection antimicrobienne d'un produit cosmétique




Contents Page

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.
This second edition cancels and replaces the first edition (ISO 11930:2012), which has been technically revised. The main changes compared to the previous edition are as follows.
Two types of diluents, composition 1 and composition 2 can be used as the diluents for bacteria and Candida albicans on the revised version (5.2.3).
5.6.2 Paragraph 2 has been changed to “When counts of surviving microorganisms obtained in 5.6.1.4 c) are less than 30 for bacteria and C. albicans or less than 15 for A. brasiliensis at the dilution where neutralization has been checked, record the number of colonies on Petri dishes and express results by multiplying by the dilution factor. If no colonies are observed at the dilution where neutralization has been checked, note the result as <1 and multiply by the dilution factor.”

Introduction

This document is designed to be used in the overall evaluation of the antimicrobial protection of a cosmetic product.
The antimicrobial protection of a product can come from many sources:
chemical preservation;
inherent characteristics of the formulation;
package design;
manufacturing process.
This document defines a series of steps to be taken when assessing the overall antimicrobial protection of a cosmetic product. A reference method for a preservation efficacy test (challenge test) along with evaluation criteria is also described in this document.
The test described in this document involves, for each test microorganism, placing the formulation in contact with a calibrated inoculum, and then measuring the changes in the microorganism count at set time intervals for a set period and at a set temperature.
The data generated by the risk assessment (see ISO 29621) or by the preservation efficacy test, or both, are used to establish the level of antimicrobial protection required to minimize user risk.

INTERNATIONAL STANDARD ISO 11930:2019 (E)
Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product

1 Scope

This document specifies a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both, when evaluating the overall antimicrobial protection of a cosmetic product.
It comprises:
a preservation efficacy test;
a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not considered low risk, based on a risk assessment described in ISO 29621.
The preservation efficacy test is a reference method to evaluate the preservation of a cosmetic formulation. It is applicable to cosmetic products in the marketplace.
This test does not apply to those cosmetic products for which the microbiological risk has been determined to be low according to Annex A and ISO 29621.
This test is primarily designed for water-soluble or water-miscible cosmetic products and can be used with modification to test products in which water is the internal (discontinuous) phase.
NOTE This test can be used as a guideline to establish a development method during the development cycle of cosmetic products. In this case, the test can be modified or extended, or both, for example, to make allowance for prior data and different variables (microbial strains, media, incubation conditions exposure time, etc.). Compliance criteria can be adapted to specific objectives. During the development stage of cosmetic products, other methods, where relevant, can be used to determine the preservation efficacy of formulations.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
ISO 21148:2017, Cosmetics — Microbiology — General instructions for microbiological examination
ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 21148 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
ISO Online browsing platform: available at https://www.iso.org/obp
IEC Electropedia: available at https://www.electropedia.org/
3.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
3.2
cosmetic product
cosmetic formulation (3.1) that has undergone all stages of production, including packaging in its final container
3.3
antimicrobial protection of a cosmetic product
ability of a cosmetic product (3.2) to overcome microbial contamination that might present a potential risk to the user or to the aesthetic and functional integrity of the product, during intended use
Note 1 to entry: The overall antimicrobial protection includes preservation of the formulation, the specific manufacturing process and protective packaging.
3.4
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation (3.1)
EXAMPLE
Preservatives, multifunctional compounds, hostile raw materials, extreme pH, low water-activity values.
3.5
reference method
method applied by interested parties to assess a product on the market and in case of dispute
3.6
development method
in-house method
method used during the development stage of a product before the product is put on the market
3.7
consumer
end user of a cosmetic product (3.2)

Bibliography
[1]
ISO 22716, Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
[2]
ISO/IEC Guide 51, Safety aspects — Guidelines for their inclusion in standards
[3]
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity
[4]
Ibrahim Y.K.E., Geiss H.K., & Sonnag H.-G. Alternatives to the traditional preservatives, SöFW, 118, June 1992
[5]
Lück E., & Jager M. Antimicrobial food additives; characteristics, uses, effects, Springer (ed), 1995, pp. 122–124
[6]
Application of Water Activity Determination to Nonsterile Pharmaceuticals Products USPC, Inc., 30(5), 2006, in-process revision: <1112>
[7]
CTFA Microbiology guidelines 2007
[8]
Russell N.J., & Gould G.W. Food preservatives, Blackie and Son Ltd., 1991, pp. 1617
[9]
Denyers S., & Baird R. Guide to microbiological control in pharmaceuticals, 1990, pp. 16–17 and p. 285
[10]
Rahman M.S. Handbook of food preservation, Marcel Dekker, Inc., 1999, pp. 95–172 and p. 386
[11]
Meier M., Fisher F.X., Keller M., & Halfmann H.-J. Influence of alternative propellants on microbial viability in comparison to chlorofluorocarbons, Pharm. Ind., 58, pp. 7882, 1996
[12]
Declerck J., Caire-Maurisier F., Genot P., Levacher E., Michaut A., Scheiber G., & Tardivet S. Les gaz propulseurs: les HFC (hydrofluorocarbones) alternatives aux CFC (chlorofluorocarbones) pour les préparations pharmaceutiques pressurisées, SFSTP Pharmapratiques, 16(1), January/February 2006, pp.6172
[13]
Bloomfield S.F., Baird R., Leak R.E., & Leech R. Microbial Quality Assurance in Pharmaceuticals, Cosmetics and Toiletries, Ellis Horwood Series in Pharmaceutical Technology, 1988, p. 78
[14]
Sawyer E., Green B., & Colton H. Microorganisms survival in non-CFC propellant P134a and a combination of CFC propellants P11 and P12, Pharmaceutical Technology, March 2001, pp. 9096
[15]
Brannan D.K. Packaging’s role in preservation, Cosmetics and Toiletries, 113, Abilene Christian University, Abilene, TX, April 1998
[16]
Sharpell F., & Manowitz M. Preservation of cosmetics, Disinfection, sterilization and preservation, fourth edition, Seymour S. Block — Lea & Febiger, 1991
[17]
Ibrahim Y.K.E., & Sonnag H.-G. Preservative potentials of some aerosol propellants, Effectiveness in some pharmaceutical oils, Drugs made in Germany, 2, 1995
[18]
Kabara J.J., & Orth D.S. Principles for product preservation, Preservative-free and self-preserving cosmetics and drugs, principles and practice, Marcel Dekker, Inc. (ed.), New York, 1997, pp. 1–14
[19]
Friedel R.R., & Cundell A.M. The application of water activity measurement to the microbiological attributes testing of nonsterile over-the-counter drug products, Pharmacopeial Forum, 24(2), March–April 1998
[20]
Brannan D.K., & Dille J.C. Type of closure prevents microbial contamination of cosmetics during consumer use, Appl. Environ. Microbiol., 56, 1990, pp. 14761479
[21]
Enigl D.C., & Sorrels K.M. Water activity and self-preserving formulas, Preservative-free and self-preserving cosmetics and drugs, principles and practice, Marcel Dekker, Inc. (ed.), New York, 1997, pp. 45–47
[22]
Misock J., & et al “Report For International Cooperation On Cosmetics Regulation Regulators & Industry Joint Working Group (JWG): Review of ISO Microbiological Standards: Guidelines for Cosmetic Preservation and Product Protection” June 6, 2017



ICS 07.100.40
Price based on 22 pages



ICS 07.100.40
Price based on 22 pages